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Discovery is the process of exploring new and unique molecules, compounds and biologics that may have the potential to treat or prevent disease. We consider variables such as disease prevalence, unmet medical needs and current treatment options when identifying a preclinical candidate (PCC).
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It takes about 10 years for a new product to reach the marketplace after the initial discovery.
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During this phase, the active pharmaceutical ingredient is produced to create the material that will be supplied for the clinical studies.
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1 in every 5,000 compounds that enter discovery and progress to preclinical development actually become an approved drug.
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Clinical studies determine the safety and efficacy of our products by gathering evidence through testing and analysis in trial volunteers — first in healthy volunteers, then in those with the disease. Once we have sufficient safety and efficacy data, we file an application with the information we know about the product — including study data, analyses and reports — with a regulatory agency (such as the U.S. Food and Drug Administration) for approval.
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Less than 12% of investigational medicines that enter clinical testing make it to approval.
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Manufacturing is the process of industrial-scale production, packaging and distribution of our medicines and vaccines. The process varies from product to product but is always in full compliance with all regulations and Good Manufacturing Practices (GMPs, also referred to as "cGMPs" or "current GMPs") to ensure a compliant, reliable supply for our patients.
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GMP regulations outline the minimum quality standards for manufacturing and vary by country. Each country has its own agency to monitor meeting the regulations and requirements.
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Once a product is approved and manufactured, we promote it — through education and awareness campaigns — to customers, including physicians, health care providers, pharmacies, patient populations, wholesalers and governments. With a customer- and data-focused approach, we develop a brand strategy to create a unique impression for each product.
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Marketing teams are key to creating the campaigns to educate stakeholders (customers) about the efficacy and safety of our products to ensure appropriate use.
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Post-marketing begins when the medicine or vaccine is released to the market. It includes activities to monitor and evaluate the product for safety and efficacy in a real-world setting.
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Companies monitor approved medicines for as long as they are on the market. This meets regulatory reporting requirements, provides internal reporting for ongoing analyses and supplies data to support the safety of the product.
